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الأربعاء - جمادى الآخرة 12, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-27-11-25-1163
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Tempus Pro Monitor
الأجهزة المتأثرة
Tempus Pro Monitors that have IBP enabled or use an external USB 2- Channel IBP Module. Product Description (Part Number): -Tempus Pro Monitors (00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R) -USB 2-Channel IBP Module (01-2017) Please refer to the attachment for more details.
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd
سبب المشكلة
The User/Operator Manual references the term ‘Invasive Pressure’, which includes Intracranial Pressure (ICP) and Bladder Pressure (BDR) as selectable channel labels. However, these measurements on the Tempus Pro Monitor have not been tested or validated for accuracy. The device is only cleared for Invasive Blood Pressure (IBP) measurements.
الإجراء التصحيحي
Please follow "actions that should be taken by the customer / user to minimize risks for patients or users" in the attachment. A follow-up communication regarding further actions will be sent to all affected customers by Philips after completion of current investigation. Manufacturer's Action: Instructions.
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